Orchestra BioMed wins breakthrough nod for Virtue SEB

From Medical Design & Outsourcing

• Steris wins second EUA to decontaminate up to 30m respirators per day
  Steris (NYSE:STE) has won an FDA emergency use authorization (EUA) for a new steam sterilization method to decontaminate used N95 respirators. The EUA covers the new Steris Steam Decon cycle to decontaminate 3M 1860, 3M 1860S, and 3M 1804 NIOSH-approved N95 respirators that are or might be contaminated with SARS-CoV-2 and other pathogenic microorganisms. The FDA… […]
• Raumedic supplies adhesive for production of thousands of ventilators
  When the federal government tapped Hamilton Medical to produce tens of thousands of ventilators for COVID-19 patients, the company turned to its long-term partner Raumedic for a special silicone adhesive. The adhesive is solvent- and plasticizer-free, easy to use and bonds silicones to each other and to other materials, such as metal or plastics, according… […]
• FDA signals PPE shortage, issues EUA for more
  The FDA has issued a call for manufacturers to produce more non-surgical gowns and other personal protective equipment (PPE) as the coronavirus pandemic makes its way across the country. The emergency use authorization issued Friday also listed conductive shoes and shoe covers, operating room shoes and shoe covers, surgical helmets and caps and other surgical accessories. The… […]
• Ga. warehouse workers sue Sterigenics, ConMed over EtO exposure
  Fifty-three people who worked in an Atlanta-area warehouse that stored medical devices sterilized by ethylene oxide (EtO) filed suit this week against Sterigenics and its parent company over exposure to the gas. The plaintiffs or their families claim that long-term EtO exposure to the sterilized devices, which they unloaded, handled, warehoused and distributed, caused multiple… […]
• FDA eases regs on certain device changes during pandemic
  The FDA will allow limited changes to certain devices so medtech companies can address manufacturing and supply chain issues due to COVID-19-related disruptions. In a guidance released yesterday, the agency said it would allow changes to devices approved through its premarket approval (PMA) and humanitarian device exemption (HDE) pathways as long as those changes do… […]
• 15 heart devices that could boost their manufacturers’ sales
  Before the coronavirus pandemic hit, medtech companies large and small were making notable news with a number of innovative heart devices. Some of these same companies took a big hit to their bottom lines when the danger of spreading COVID-19 and using up precious personal protective equipment convinced hospitals to limit non-urgent procedures. Now hospitals… […]
• This wearable could help people practice safe distancing amid COVID-19
  Imec spinoff Lopos, with the Ghent University (Belgium) announced the Lopos SafeDistance wearable for promoting safety during the COVID-19 pandemic. As businesses attempt to return to in-person activities, the collaboration designed the wearable device to warn employees through an audible or haptic alarm when they are violating social distancing guidelines as they approach each other.… […]
• FDA launches COVID-19 research initiative
  The FDA has entered an agreement with healthcare analytics company Aetion to research urgent questions about COVID-19. The New York City-based company said the research will support FDA objectives to explore the natural history of the disease, as well as treatment and diagnostic patterns using relevant, novel data sources and analyzing these data according to well-established principles.… […]
• Medtronic execs see quick recovery, increased M&A
  If Medtronic’s troubling Q4 report offers a snapshot of a company hit hard by COVID-19, the next image in the sequence may show a faster-than-expected recovery and increased merger-and-acquisition of smaller companies. In the quarterly call on Thursday morning, Medtronic CEO Geoff Martha and CFO Karen Parkhill expressed optimism that the company’s businesses already are showing signs… […]
• Webinar: How COVID-19 is changing medical device regulation, clinical trials and reimbursement
  Tuesday, June 23, 2020 11:30 a.m. eastern time / 8:30 a.m. pacific time     As the life sciences industry works to contain the COVID-19 outbreak, it is clear that the dynamics of the medical device and digital health industries are being disrupted. Going virtual is the new normal and executives of medtech and healthtech… […]
• IMDRF recommends UL 2900 compliance for medical device cybersecurity
  By Stewart Eisenhart, Emergo Group Recent guidance published by the International Medical Devices Regulators Forum (IMDRF) that covers medical device cybersecurity best practices includes recommendations that manufacturers comply with the UL 2900 set of standards for network-connectable devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post… […]